Case Study: Improved Risk Management SOP

A small, but growing, start-up medical device company wanted to start taking their quality system to the next level. Since they outsource many of their engineering and manufacturing activities, they needed a significantly more robust risk management process that could work seamlessly with each outsource company's risk management program.

AlvaMed determined which elements of a complete risk management program were most appropriate to be conducted by the start-up company and which should be left to the outsource companies. AlvaMed then drafted a suitable Risk Management SOP. As part of this process, AlvaMed worked closely with the start-up company, proposing various alternatives in matters such as risk evaluation tables, so that the final SOP was tailored to their specific circumstances.

The system was reviewed within the company and accepted as part of their quality system.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control